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Requirements for Human Subject Protection Training
WIRB requires investigators to verify on the initial review submission form and
each Continuing Review Report form that each member of the research team has successfully
completed training in human research subject protection. Your institution may have
additional training requirements, please check with your institutional official.
Please note that HIPAA training or prior research experience alone do not satisfy
this requirement for training in human subject protection. WIRB's expectation is
that training include topics such as ethical principles related to human subject
protections, federal regulations for protection of human subjects, and Good Clinical
Practice.
When standard of care therapy is part of the research, WIRB only requires this training
of staff members who are involved in the consent process, recording of data, submission
of unanticipated problem reports or other procedures specific to the research.
WIRB accepts training completed in a variety of formats (e.g., online modules, live
seminars, college courses, self-study texts that provide CEU or CME credit) and
from a variety of sources (e.g., government entities, non-profit institutions, professional
organizations, and commercial businesses).
Click here for a sampling of training resources.
Physicians and their teams who request approval of use of a humanitarian use device
or treatment use of a investigational product are not required to complete human
subject protection training.
If you have questions regarding WIRB training requirements, please contact Client
Services at clientservices@wirb.com
or 1-800-562-4789.
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